WHO Revised

CSSD Manual and Guidelines

Dr Nizam Damani

5th ICAN Conference

3rd November 2014

Room 1: 10:30-12:00

1

Outline

• Setting the scene

• What is in the revised edition of the

Decontamination Manual

‘Decontamination and Reprocessing Manual

for Healthcare Facilities’

2

Term DECONTAMINATION includes

cleaning, disinfection and sterilization

Processing medical devices

• Reprocessing of medical devices is

common worldwide due to:

– cost constraints

– availability of adequate no. of devices

3

Reprocessing of medical devices

COUNTRIES % REUSE REFERENCES

BRAZIL 97(including angiography & cardiac catheters)

Amaranta et al., 2008

SPAIN 80 El Mundo, 2005

JAPAN 80–90 Koh A & KawaharaK, 2005

AUSTRALIA 50 (1980s) Collignon et al., 1996

GERMANY 40 Ischinger TA, 2002

DENMARK 37 Christensen PJ et al. 1999

CANADA 28 Polisena et al., 2008; Hailey et al., 2008

In developed countries, reuse of single-use items is less common

but may include expensive products.

Walter P et al. International Journal of Hygiene and Environmental Health 2010; 213:302–307

Processing medical devices

Full scale of adverse events

(including HCAIs) due to inadequate

decontamination and re-processing

of medical devices is unknown

6

Tip of the Iceberg

Asymptomatic/carrier

infections eg Hep B & C,

MRSA

Under-reporting of cases

due to lack of surveillance

and/or follow up

Under-reporting of infections/outbreaks due to reuse &

inadequate decontamination of medical devices

Difficulty identifying single

healthcare exposure

Barriers to investigation

and/or resource constraints

Risk of cross infection due to inadequate decontamination of medical devices

Spread of

BLOOD BORNE VIRAL infections e.g. Hepatitis B&C,

HIV

• Re-use of needles & syringes

• Inadequate cleaning and decontamination of items in dentistry and other settings

Risk of

SURGICAL SITE INFECTIONS

• Inadequate sterilization of surgical instruments

• Use of non-sterile gloves, wound dressings and other items

Spread of

MULTI-DRUG RESISTANT MICROORGANISMS

Risk of

Catheter associated UTICentral Line infections

Ventilator Associated Pneumonia

• Re-use of single-use sterile devices

• Inadequate cleaning and decontamination of items/equipment and environment between patients

8

Central Sterile Supply Dept. in a Public Sector Hospital

Decontamination facilities in low to middle income countries

Courtesy : Dr Pessoa-Silva

WHO (PAHO) Manual: 2009

CONTENTS1. Introduction

2. Physical areas and personnel of the sterilization

plant

3. Personal protective equipment

4. Hand washing

5. Cleaning of materials

6. Preparing and packaging materials

7. Basic guidelines for disinfection and sterilization

8. Disinfection

9. Sterilization

10. Correctly loading the sterilizer

11. Handling, transporting and storing materials

12. Methods for controlling the sterilization process

13. Failures in the sterilization process

14. Validating the sterilization process

15. Quality indicators for the sterilization plant

16. Re-use of a single use medical device

17. Environmental cleaning and disinfection of the

sterilization plant

18. Occupational hazards

19. Waste management

20. Terms related to sterilization

21. Bibliography

2009

The Members of the Working group

2014 : New revised WHO Manual

CONTENTS• Introduction

• Essential elements of Quality Management System

• Risk management in decontamination & sterilization

• Risk assessment in Sterile Service

• Sterilization options which are currently available

• Sterile Service Dept.

• Cleaning and processing of Medical Devices

• Inspection, assembly and packaging (IAP) for

reprocessing

• Transporting medical devices to and from the

CSSD

• Assessment and Purchase of Medical Devices

• Chemical Disinfectants

• Decontamination of Endoscopes

• Flash sterilization (immediate use steam

sterilization)

• Processing of devices in community based facilities

(including dentistry)

• Dealing with prion disease (Creuztfelt-Jacob

Disease Variant, CJDv)

• Glossary of terms

• References

2015: Plan to develop

•Teaching material

•Validation and audit tools

•Aide memoires and wall charts

Decontamination in resource limited

countries - is this possible?

YES !

Continuous process improvement based on many

small, evolutionary steps rather than

revolutionary innovations

The Juran Trilogy diagram(Structured approach to quality improvement)

QUALITY PLANNING

• Recognize that

decontamination &

sterilization is a

priority

• Planned approach

on how to achieve

these objectives

• Raise awareness

and provide

education and

practical training

• Provide resources

and tools based on

the local risk

assessment and

need

QUALITY IMPROVEMENT (Quality Control)

• Prioritize & implement Good Practice

• Introduce audit and keep documentation of

the processes used for decontamination

• Provide feedback with aim to improve

service and provide support

New zone of

Quality Control

Thank you